FITTING GUIDE & TIPS FOR ACHIEVING · PDF fileProprietary HydrolEyes™ surface science allows for ... with Rx in minus cylinder form, enter the patient’s sphere ... total clearance

FITTING GUIDE & TIPS FOR ACHIEVING SUCCESS

mul t i foca la g e l e s s v i s i o n n e a r a n d f a r T M

mul t i foca la g e l e s s v i s i o n n e a r a n d f a r T M

1

Overview 2...............................................................................................................................

Patient Candidates 2...............................................................................................................................

Key Features of SynergEyes® Multifocal 3...............................................................................................................................

SynergEyes® Multifocal Lens Design 4...............................................................................................................................

Trial Lens Set 5...............................................................................................................................

Key Fitting Principles 6-7...............................................................................................................................

Fitting SynergEyes® Multifocal 8-13...............................................................................................................................

Troubleshooting & Tips for Success 14-20...............................................................................................................................

Other Tips for Success 21...............................................................................................................................

Fitting Flowchart 22-23...............................................................................................................................

Available Parameters back cover...............................................................................................................................

Contact Information back cover...............................................................................................................................

Contents

The SynergEyes® Multifocal hybrid contact lens applies the centration and stability of the hybrid platform to a simultaneous vision lens design that is ideal for presbyopes. The combination of a high-Dk rigid gas permeable center and a low-water, non-ionic soft skirt gives presbyopic patients the best of both worlds: the crisp visual acuity of a rigid lens and the all-day comfort and stability of a soft lens.

O ver view

Patient Candidates

· Presbyopes with corneal astigmatism

· Soft multifocal toric wearers desiring more consistent vision and improved acuity both day and night

· RGP bifocal wearers looking for improved comfort and elimination of irritating debris that collects underneath RGP lenses

· Soft multifocal wearers wanting sharper visual acuity

· Monovision wearers who are seeking more balanced visual correction that offers better stereopsis and improved depth perception

· Previous contact lens wearers that dropped out due to discomfort, less-than-optimal vision, night vision problems or instability on the eye

2

Key Features of SynergEyes® Multifocal

1. Hybrid platform provides excellent centration and stability to deliver full binocular vision at all distances that is not affected by eye movement

2. Concentric, center near design concentrates the optics within two distinct areas of focus: one for distance and one for near

3. Simultaneous vision system provides sharp near, distance, and intermediate visual acuity

4. Astigmatism correction without the inconsistent axis shift often associated with toric lenses

5. 100 Dk rigid gas permeable center allows high oxygen transmission to maintain corneal health

6. Hydrophilic, non-ionic soft skirt provides all-day comfort

7. Uniform edge engineered for maximum comfort across full power range

8. Exclusive patented HyperBond™ junction makes SynergEyes hybrid lenses much stronger than any other marketed hybrid contact lens1

9. Proprietary HydrolEyes™ surface science allows for outstanding in vivo wetting and all-day comfort

1 Data on file.

PRECIS ENEARVISION

PRECIS EDISTANCEVISION

3

4

SynergEyes® Multifocal Lens Design

· Rigid lens optic zone is 7.8mm, with a peripheral curve that blends across the junction to the soft skirt

· Available in 10 base curves ranging from 7.10mm to 8.00mm in 0.10mm steps

· Each base curve comes with two skirt curve options: 1.0mm or 1.3mm flatter than the base curve

· Thicker enhanced profile lens design is also offered to reduce flexure resulting from high amounts of corneal astigmatism

· Two segment sizes, 1.9mm and 2.2mm, and four add powers are available: +0.75D, +1.25D, +1.75D, and +2.25D

8.4 mm

Rigid Center Diameter

Overall Diameter14.5 mm

Non-Ionic 27% Water Hydrogel Skirt

Paragon HDS® 100 Rigid Center

100 Dk

1.9mm & 2.2mmNear Segments

5

Trial Lens S et

To enable practitioners to check the fit of the lens and to allow patients to experience the acuity and comfort SynergEyes lenses offer, a 20-lens trial set is available. Using the trial lens set typically reduces overall chairtime by minimizing the number of exchanges required.

The trial set includes lenses in each of the 10 base curves ranging from 7.10mm to 8.00mm in 0.10mm steps. The 7.30mm to 8.00mm base curves have the steep (1.0mm) skirt, and the 7.10mm and 7.20mm base curves have the flat (1.3mm) skirt. All of the trial lenses are plano sphere power and +1.75D add power. Both segment sizes, 1.9mm and 2.2mm, are included in the trial lens set.

If conducting a fluorescein evaluation with the trial lenses, it is important to use high molecular weight fluorescein and place it in the bowl of the lens before inserting the lens.

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Key Fitt ing Principles

When fitting the SynergEyes® Multifocal lens, the goal is to find a base curve that supplies enough sagittal depth to vault over the central cornea and a skirt curve that provides fit alignment.The SynergEyes® Multifocal lens is intended to be fit on normal, healthy corneas; the lens is not designed for irregular corneas. It is important that the lens always be fit steeper than flat K. A successful SynergEyes fit results in a lens that rides on a layer of tears. By creating this tear layer underneath the lens, an effective tear pump mechanism is produced. When selecting the initial lens, apply the following guidelines:

· Spherical corneas do well with a base curve 1.00D steeper than flat K

· Astigmatic corneas (with up to 1.50D of corneal astigmatism) require a base curve 1.50D steeper than flat K

· Patients with more than 1.50D of corneal astigmatism may require an even steeper base curve

Ideal SynergEyes® Multifocal Fit

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Key Fitt ing Principles, co n t i n u e d

The SynergEyes® Multifocal lens may be fit without the use of fluorescein; however, fluorescein evaluation using high molecular weight fluorescein (i.e., Fluoresoft®) is recommended for the first 3-5 fits or until you are comfortable fitting the hybrid platform. When using the trial lenses to evaluate the fit, it is important to use high molecular weight fluorescein and place it in the bowl of the lens before inserting the lens.

Although it may seem counter-intuitive, the appropriate way to correct a tight/flat fitting lens in most cases is to steepen the base curve. Lenses with little or no movement that appear tight actually mean the lens is touching too much of the cornea. Steepening the base curve will correct this fit.

Flat Fitting Lens

Steep Fitting Lens

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Fitting SynergEyes® Multifocal

Before Fitting:· Conduct a tear analysis to assess the

quantity and quality of tears and address any dry eye conditions before fitting the lens

· Dry eye disease can cause reduced wearing time and comfort problems with any contact lens

· Properly addressing and treating dry eye is extremely important and may even be the difference between a successful and unsuccessful fit.

Step 1: Selecting the Initial LensUse the handheld slide rule to determine the base curve and skirt curve of the initial lens based on K readings.

Turn the slide rule to the reverse side and, with Rx in minus cylinder form, enter the patient’s sphere power (NOT the spherical equivalent) into the window on the left. The recommended sphere power will appear in the window on the right.

Alternatively, use the electronic calculator to determine the initial lens parameters.

Note: Vertex adjustments for power are already factored into the slide rule calculations.

9

Fitting SynergEyes® Multifocal, continued

To choose the appropriate segment size, determine the patient’s dominant eye, or eye preference for distance and near vision, and then choose the segment size.

• For most patients, select the 1.9 segment for the dominant or distance eye and the 2.2 segment for the non-dominant or near eye.

• Patients with small pupils or greater demand for distance vision may prefer 1.9 segments on both eyes.

• Patients with large pupils or greater demand for near vision may prefer 2.2 segments on both eyes.

Once the segment sizes have been determined, select the patient’s add power using the following chart:

Select the trial lens in the recommended parameters and follow the instructions for insertion on Page 10.

<45 +0.75 +0.75 or +1.25

45 – 49 +1.25 +1.25

50 – 57 +1.75 +1.75

>57 +1.75 +2.25

Patient’s Age Dominant Eye Add Non-Dominant

Eye Add

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Step 2: Insert the Trial Lens 1. Stabilizing the lens between the index and

middle fingers (see photo), instill 1 drop of high molecular weight fluorescein (i.e. Fluoresoft®) into the bowl of the lens and fill the rest of the bowl with saline. Alternatively, the bowl of the lens may be filled with saline only; the use of fluorescein may not be necessary to evaluate the fit of the lens.Bowl of lens filled with

fluorescein and saline

Patient position during insertion

Patient holding one lid back

2. Ask the patient to lean forward and tuck their chin to chest. The patient’s nose should be pointing toward the floor.

3. Have the patient hold one lid back, while you retract the other and insert the lens.

4. Allow the excess solution to dissipate for approximately 15-30 seconds.

5. Observe lens movement and fluorescein pattern (if using fluorescein) and evaluate the lens/cornea fitting relationship.

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Step 3: Evaluate the FitAn ideal SynergEyes® Multifocal fit will exhibit:• Apicalclearanceoverthecentralcornea(theoptimum

fit shows no touch in the rigid zone of the lens – total clearance of the central cornea)

• LightlandingattheRGPperiphery• Alignmentunderthesoftskirt• Softskirtfreeofscleralimpingement• Softskirtfreeofedgefluting• Lensfreetomoveonlidpush-up• Nearsegmentcenteredoverthepupilarea

Apical Clearance as Indicated by Slight Fluorescein Pooling

Slight FluoresceinPresence at Limbus

with Scleral Support from Soft Skirt

Light Landing at the RGP Periphery with

Fluorescein Dispersing Through Junction

Ideal SynergEyes® Multifocal Fit

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Step 3: Evaluate the Fit, continuedIt is important to confirm centration of the near segment: slight de-centration within the pupil area may be acceptable, but it could also cause double vision or unacceptable distance or near vision.

There are two different methods that can be used to confirm centration of the near segment:

1. Use retinoscopy, retro-illumination, or corneal topography over the lenses to evaluate the position of the segment.

2. With the lens on the eye, pull down the lower lid and instill a drop of Fluoresoft® inside the lower lid. Have the patient blink 2-3 times. Use the slit lamp with the cobalt blue filter to view the location of the near segment. Please note that the use of Flura-Safe® with this technique will not properly highlight the near segment.

Slight nasal de-centration may still provide acceptable near vision, but temporal de-centration could affect visual acuity. If the segment is more than slightly de-centered, try a steeper base curve and skirt curve.

If good centration is unattainable, the patient may not be a candidate for this lens design.

De-Centered Near Segment

Near Segment - Inside Yellow Circle

Pupil

De-Centered Near Segment

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Step 4: Demonstrate Visual Acuity

When performing a trial lens fit, you have the opportunity to allow the patient to experience the crisp vision delivered by the SynergEyes® Multifocal.

With the trial lens on the patient’s eye:

1. Over-refract for distance vision.

2. Use a trial frame with distance over-refraction to demonstrate distance vision in normal light.

3. With the optimal distance over-refraction still in place, check the patient’s near vision focal range. All diagnostic lenses have the +1.75D add power.

a. If the near focal point is too far out, it can be moved closer with an additional +.50D in the add.

b. If the focal point is too close for the patient’s needs, it can be moved further out by reducing the add power by either -.50D or -1.00D.

c. Use handhelds in either -0.50D, -1.00D or +0.50D over the patient’s ideal distance Rx to demonstrate near vision at the patient’s preferred range in normal light.

d. Power adjustments to the add may be most effective when made to one lens at a time.

4. Adjust parameters if necessary before ordering.

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Troubleshooting & Tips for Success

Bubbles Because air bubbles can affect the appearance of the fluorescein pattern, it is critical to eliminate them prior to evaluating the fit. Bubbles are almost always representative of an insertion error – not a fitting error.

A bubble does not necessarily mean the lens is too steep.

• Ifabubbleisseenunderneaththe lens upon insertion, the lens has not been inserted properly. Insertion bubbles may occur because there are areas within the optic zone that could trap air pockets if the lens is not inserted properly.

• Iftherearebubblesunderthe lens, you must remove the lens and re-insert it. Make certain that the bowl of the lens is filled to the TOP with saline.

• Bubblesarelesslikelytooccur if the patient maintains fixated gaze (straight to the floor) throughout the insertion process.

Troubleshooting & Tips for Success

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Bubbles are indicated by a

very distinct outer edge

Touch patterns typically have a less defined edge.

Bubbles vs. Touch

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Troubleshooting and Tips for Success

Unacceptable Distance Vision

If the patient is experiencing unacceptable distance vision:

1. Re-confirm distance Rx

• IfachangeismadetothedistanceRx,doublecheckthe patient’s near vision with this change. If near vision is now hindered by the adjustment to the distance Rx, re-establish the patient’s preferred near focal range by adjusting the add power.

2. Ensure that the lens is not flexing

• Ifcylinderispresentinover-refraction,performkeratometry or topography over the lens.

• Ifon-eyelensflexure>.50Disobserved,orderthethicker enhanced profile lens.

3. If you have confirmed the distance Rx, and on-eye flexure is not observed, revisit the seg size strategy

• Considerdecreasingthesegmentsizeonthenon-dominant eye from 2.2mm to 1.9mm.

Non-Dominant Eye 2.2mm seg

Non-Dominant Eye 1.9mm seg

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Unacceptable Near Vision

Do not make any changes until the patient has been wearing the lenses for at least two weeks – near vision usually improves as the patient adapts to the new optical system.

If unacceptable near vision persists:

1. Check centration of the near seg

• Ifde-centered,steepenbasecurve*.

2. Re-confirm the patient’s preferred near focal range

• Usehandheldlensesin+/-.50Dincrementstoachievepatient's preferred near vision range.

• Mostpatientsdobestwithanaddpowerthatislessthan their spectacle add .

3. If the seg is well centered, near vision is unacceptable at any distance, and over-refraction fails to provide acceptable near vision, revisit the seg size strategy

• Considerincreasingthesegsizeonthedominanteyefrom 1.9mm to 2.2mm.


* Please note that every 0.1mm base curve change willrequire a 0.50D adjustment in power. Employ the SAM/FAP rule.

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Unacceptable Comfort

If patient experiences persistent discomfort, conduct a fluorescein evaluation to assess the fit of the lens.

1. Central bearing indicates the lens is too flat, and the base curve should be steepened

2. Excessive central pooling indicates the lens may be steeper than necessary, and a flatter base curve may improve comfort

3. Look at the rigid/soft junction – seal off or bearing can be corrected with a steeper skirt – if the patient is already wearing the steeper skirt, call SynergEyes Consultation to discuss ordering the lenses with a "Peripheral Blend"

4. If the base curve and skirt curve are determined to be optimal and discomfort persists, call SynergEyes consultation to discuss ordering the lenses with a “Peripheral Blend”

The Peripheral Blend design slightly flattens the RGP periphery and soft skirt to create a less pronounced landing zone across a broader area of the peripheral cornea. Candidates for the Peripheral Blend include

patients with small corneas or high eccentricity values and any patient experiencing discomfort, tightness, or

removal issues when all other parameters are optimized.

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Base Curve Too Steep - Flatten Base Curve (Ex. 7.6mm BC -> 7.7mm BC)

Skirt Curve Too Flat - Steepen Skirt Curve(Ex. 1.3mm SC -> 1.0mm SC)

Base Curve Too Flat - Steepen Base Curve (Ex. 7.7mm BC -> 7.6mm BC)

Excessive Fluorescein Pooling

Centrally

Central Bearing

Fluorescein Pooling Under the Periphery

of the Soft Skirt

Heavy Bearing at RGP Periphery with

Complete Absence of Fluorescein

Lack of Fluorescein in RGP Periphery &

Junction Area

If the patient complains of late-day discomfort or an uncomfortable lens several weeks or months post-dispense:

1. Check the surface of the lens for deposit build-up

• Thepatientmaynotbedigitallycleaningeveryday

• Enzymecleanermaybenecessary

2. The patient may be experiencing solution sensitivity

• Switchthepatienttoaperoxide-basedcaresystem–Clear Care® is highly recommended

3. Ensure the patient does not have untreated dry eye disease

• Dryeyediseaseisoftentherootcauseofcomfortproblems with the SynergEyes® Multifocal lens

• Takenecessarystepstotreatthedryeyeproblem

4. Have the patient put 1-3 lubricating drops in the bowl of the lens prior to insertion

• Useofnon-preservedsolutionsorrewettingdropsis recommended for patients with symptoms of lens discomfort or dry eyes


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Other Tips for Success

1. Small changes in lens parameters can make a big difference.

• Consider making changes to one eye at a time to test the results before making adjustments to both eyes.

• After each change, give the patient the opportunity to “test-drive” the new parameters in his or her own environment.

2. Adaptation is similar to prescribing progressive-addition spectacles; therefore, limit changes on the first day.

3. For additional trouble shooting tips or guidance, call SynergEyes consultation at 877.733.2012, Option 2.

Consider making changes to one eye at a time 21

Distance vision stillunacceptable

Distance VA acceptable – con�rm add power with

new distance Rx

Distance VA not acceptable –perform sphero-cylindrical

over-refraction

No on-eye �exureobserved

Consider 1.9mm segs OU

Unacceptable DistanceVision

Over–refract using hand-held lenses –adjust distance Rx accordingly

Cylinder present –perform over-keratometry

or over-topography

On-eye �exure observed

OrderEnhanced Pro�le lens

Re-order lenseswith new parameters


Unacceptable NearVision

Use -0.50D/+0.50Dhand held lenses to

re-establish preferredworking distance

Con�rm distance Rx Con�rm lens centration

Within preferred working distance At any near range

Distance Rx accurate Distance Rx adjusted Well-centeredDe-centered

Place new distance Rxover-refraction in trial frame


Steepen base curve 0.10mm

Remains de-centered

Patient may not begood candidate

Re-order lenses with new parameters

Use the following flow chart when evaluating the fit of the SynergEyes® Multifocal.

SynergEyes® Multifocal Fitting Flowchart

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Distance vision stillunacceptable

Distance VA acceptable – con�rm add power with

new distance Rx

Distance VA not acceptable –perform sphero-cylindrical

over-refraction

No on-eye �exureobserved


Unacceptable DistanceVision

Over–refract using hand-held lenses –adjust distance Rx accordingly

Cylinder present –perform over-keratometry

or over-topography

On-eye �exure observed

OrderEnhanced Pro�le lens

Re-order lenseswith new parameters


Unacceptable NearVision

Use -0.50D/+0.50Dhand held lenses to

re-establish preferredworking distance

Con�rm distance Rx Con�rm lens centration

Within preferred working distance At any near range

Distance Rx accurate Distance Rx adjusted Well-centeredDe-centered

Place new distance Rxover-refraction in trial frame


Steepen base curve 0.10mm

Remains de-centered

Patient may not begood candidate

Re-order lenses with new parameters

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For additional information on fitting SynergEyes® Multifocal, please visit

www.FitSynergEyes.com.

24

To view videos of ideal lens movement, insufficient lens movement,

and excessive lens movement, visit the practitioner site at

www.SynergEyes.com.

www.synergeyes.com 877-SEE-2012

©2009, SynergEyes, Inc. PN 75058, Rev. C

Customer CarePHONE: 877.733.2012, option 1

ConsultationPHONE: 877.733.2012, option 2

SynergEyes® Multifocal Parameters

Material Paflufocon D center (hemiberfilcon A skirt)

Dk 100

Water Content 27% (soft skirt)

Diameter 14.5mm

Base Curve 7.10 to 8.00 in 0.10mm steps

Skirt Curvature 1.0(steep) & 1.3(flat)

Sphere Power +5.00D to -8.00D in .25D steps -8.50 to -20.00 in .50D steps

Add Power +0.75D, +1.25D, +1.75D, +2.25D

Add Segment Size 1.9mm, 2.2mm

Wear Indications Daily Wear

Replacement Cycle 6 Month

Lens Care Hydrogen Peroxide

In-stock parameters ship next day. Please allow 1-2 weeks for custom and Enhanced Profile lenses.

Documents

FITTING GUIDE & TIPS FOR ACHIEVING · PDF fileProprietary HydrolEyes™ surface science allows for ... with Rx in minus cylinder form, enter the patient’s sphere ... total clearance